Trial Types
What type of trial tests a small-molecule medicine — tablets, capsules, injections the “classic” clinical trial model?
A Drug trial
What do we call a group of participants who all receive the same drug or device throughout a trial?
An arm (also called a “treatment arm”)
What does IRB stand for?
Institutional Review Board
What do we call a clinical trial designed and led by an academic institution or independent researcher, rather than a drug/device company?
An Investigator-Initiated Trial (IIT)
In an actual protocol document, what is our product's “Visit Plan” officially called?
The Schedule of Events (or Schedule of Assessments)
What's the term used almost everywhere outside the US for an ethics committee (e.g., in India or the EU)?
IEC — (Independent/Institutional) Ethics Committee
True or False: Medical device trials always follow the same 4-phase system as drug trials.
False — they follow a risk-class-based path (Class I/II/III) instead
Which blinding type means neither the doctor nor the patient knows who's getting the real drug?
Double-blind
Which regulatory body approves clinical trial applications in India?
CDSCO (Central Drugs Standard Control Organisation)
Which 1994 US law lets nutritional/supplement trials skip FDA pre-approval, as long as claims are truthful?
DSHEA (Dietary Supplement Health and Education Act)
In a Phase 1 “3+3” design, what do we call a sequential group of patients tested at one dose level before the next group escalates?
A cohort
Roughly how many days does India's CDSCO trial-application review typically take?
About 90 days
Name the real vaccine trial that enrolled roughly 44,000 participants worldwide before receiving emergency authorization in 2020.
The Pfizer-BioNTech COVID-19 vaccine Phase 3 trial
Name the protocol section that defines who can — and can't — be enrolled in a trial.
Population / Inclusion-Exclusion (I/E) Criteria
True or False: IRB/IEC approval is a one-time event required only before enrollment starts.
False — it's also required annually, for every amendment, and after any safety event